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Completed

NCT Number: NCT01131871

Innovative Approaches to Diet, Exercise and Activity

The prevalence of obesity in young adults has been increasing, and excessive body weight have been linked to numerous chronic conditions including cardiovascular disease, diabetes, many forms of cancer, and numerous musculoskeletal problems. This study will focus of the development and evaluation of interventions that may be appropriate for young adults (age 18-35 years) to improve weight loss outcomes following a 24 month intervention. The primary aim of this study is to examine whether an enhanced weight loss intervention (EWLI) that includes technology components results in improved weight loss in young adults (18-35 years of age) compared to a standard behavioral weight loss intervention (SBWP) over a period of 24 months. Eligible participants will also be assessed for body composition, body fat distribution, fitness, physical activity, dietary intake, and behavioral/psychosocial measures that may be predictive of behavior change. Assessments will occur at 0, 6, 12, 18, and 24 months. Subjects will participate in a 24 month behavioral weight loss program that includes a reduction in energy intake and moderate-to-vigorous intensity exercise (progressively increasing from 100 to 300 minutes per week). The technologies added to EWLI are text messaging, a wearable device that provides feedback on physical activity, and access to a website to monitor dietary behaviors.

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Key information

Conditions

Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15203, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-35 years of age
  • Intending to be available for a 24 month intervention
  • An active cellular telephone that is capable of receiving text messaging
  • A computer and internet connectivity that can be used for the BodyMedia Fit system
  • Body mass index (BMI) between 25.0-39.9 kg/m2
  • The ability to provide medical clearance to participate in this study from their primary care physician
  • The ability to complete the baseline graded exercise test, and clearance from the study physician to participate in this study after reviewing the results from this study

Exclusion criteria

  • Unable to provide informed consent
  • Household member on study staff
  • Past or planned (within the next 24 months) weight loss surgery (e.g. gastric bypass, lap band, or liposuction); current participation in a commercial weight loss program (e.g. Weight Watcher's, Jenny Craig); current or planned enrollment in another diet/PA/weight loss intervention study
  • Report regular use of systemic steroids, prescription weight loss drugs. "Regular use" is defined as "taking this medication most days of the week for the previous month"
  • Current treatment for eating disorder
  • Cardiovascular event (heart attack, stroke, episode of heart failure, or revascularization procedure) within the last 6 months
  • Current treatment for malignancy (other than non-melanoma skin cancer)
  • Currently pregnant or gave birth within the last 6 months, currently lactating or breastfeeding within the last 3 months, actively planning pregnancy within the next 24 months
  • Investigator discretion
  • Currently taking medication that would affect heart rate or blood pressure responses to exercise (e.g., beta blockers)
  • Report losing >5% of current body weight in the previous 6 months
  • Currently treated for psychological issues, or taking psychotropic medications within the previous 6 months
  • Report taking medication that could affect metabolism or change body weight
  • Current treatment for diabetes mellitus

Treatment and study plan

Standard Behavioral Weight Loss Intervention

Behavioral

Subjects in this group will receive our standard behavioral weight control program that is delivered in an in-person group-based format. At month 7 subjects will also be given access to a study website to monitor eating and activity behaviors, and to have electronic access to standardized intervention materials. At month 7 subjects will also receive targeted study-related text messages that otherwise would have been provided in paper format.

Enhanced Weight Loss Intervention

Behavioral

Subjects in this group will participate in a weight loss intervention that includes technology enhancements. These enhancements will include the addition of intervention specific targeted and tailored text messaging and the BodyMedia Fit System® beginning at Month 7. At month 7 subjects in EWLI will also receive the same targeted study-related text messages provided to SBWP that otherwise would have been provided in paper format.

Primary outcomes

  1. weight change

    Time frame: Change from baseline to 24 months

    Body weight will be assessed on a digital scale to assess change in body weight over the 24 month intervention period.

Secondary outcomes

  1. body composition

    Time frame: 0, 6, 12, 18 24 months

    Body composition will be assessed using DXA. This will provide a measure of lean body mass, fat mass, bone mineral content, and percent body fat.

  2. cardiorespiratory fitness

    Time frame: 0, 6, 12, 18, 24 months

    A graded exercise test on a treadmill along with indirect calorimetry will be used to measure cardiorespiratory fitness. This will provide a measure of oxygen consumption and metabolic equivalents of work at the time of test termination.

  3. physical activity energy expenditure

    Time frame: 0, 6, 12, 18, 24 months

    A questionnaire and a portable device worn on the upper arm will be used to measure and quantify energy expenditure from physical activity.

  4. dietary intake

    Time frame: 0, 6, 12, 18, 24 months

    A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.

  5. psychosocial and behavioral measures

    Time frame: 0, 6, 12, 18, 24 months

    Questionnaires will be used to assess self-efficacy for weight loss and physical activity, barriers to physical activity and weight loss, expected outcomes resulting from physical activity and weight loss, perceived body image, depressive symptomotology, sleep patterns, weight history, dietary disinhibition and restraint, and behaviors typically related to weight loss (e.g., self-weighing, meal planning, etc.).

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

Enhanced Behavioral Intervention to Improve Long-Term Weight Loss in Young Adults

Acronym: IDEA

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
May 27, 2010
Registry last updated
Aug 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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